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FDA grants Fast Track designation to TTK inhibitor for the treatment of ER+/HER2- breast cancer

The designation seeks to streamline the development of new agents with potential to treat serious or life-threatening diseases

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The US biotech company Treadwell Therapeutics has announced the FDA Fast Track designation of an inhibitor of Threonine Tyrosine Kinase for the treatment of patients with ER+/HER2- advanced breast cancer.

Globally, breast cancer is the world’s most prevalent cancer and the second leading cause of cancer death in women in many countries.

The ER+/HER2- subtype is the most common subtype of breast cancer, accounting for 68 per cent of all breast cancer types, with nearly 1.2 million women living with the disease in the US alone.

Standard of care for ER+ patients is CDK4/6 inhibitors in combination with endocrine therapies, which have been very successful in prolonging survival for this patient population.

However, resistance to this treatment occurs within a median of two years. As a result, the ER+ population resistant to this standard of care is growing and is an unmet medical need requiring new treatment options.

CFI-402257 is an orally active, highly selective small molecule inhibitor for TTK – the core component of the spindle assembly checkpoint – and can help adult patients with advanced breast cancer after disease progression on prior CDK4/6 inhibitors and endocrine therapy.

“There is an urgent need for new, safe and efficacious therapies to treat ER+/HER2- breast cancer, particularly when standard of care regimens fail,” said Dr Mark Bray, Treadwell CSO and co-founder.

“CFI-402257 [the TTK inhibitor] has shown early signs of durable activity with a manageable safety profile, as a monotherapy and in combination with fulvestrant in ER+/HER2- breast cancer patients that have failed CDK4/6 inhibitors.

“We are thankful for the Fast Track Designation granted by the FDA and look forward to the continued development of CFI-402257 in ER+/HER2- breast cancer.”

The FDA Fast Track designation seeks to streamline the development and accelerate the review of new agents with potential to treat serious or life-threatening diseases and that potentially address an unmet medical need.

Drugs that are granted this designation can have more frequent interactions with the FDA, as well as potential pathways for expedited approval.

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Femtech World Awards 2026: Celebrating initiatives that move women’s health forward

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By Wolfgang Hackl, CEO, OncoGenomX Inc., Allschwil, Switzerland

As the FemTech World Awards 2026 winners are revealed, it is a privilege to reflect on the Research Award 2026 sponsored by OncoGenomX Inc., and on the exceptional standard set by this year’s finalists.

On behalf of OncoGenomX Inc., sincere thanks to every applicant and congratulations go to the nominees whose work continues to push women’s health innovation forward.

Research Awards matter because they do more than recognize excellence in a single moment; they help elevate the science, courage, and systems thinking needed to transform women’s health at scale.

This year’s three finalists represented three different but equally important forms of progress. Natural Cycles brought forward one of the largest studies ever conducted on menstrual and ovulatory patterns in perimenopause, analysing nearly one million cycles from more than 197,000 women across over 140 countries.

That project stood out for both its dataset scale and its ability to translate new evidence into a regulated product designed to support women navigating a historically under-researched life stage.

IVI RMA stood out for scientific rigor and clinical precision. Its multicenter, double-blinded, non-selection study on non-mosaic segmental aneuploid embryos offered high-quality evidence on implantation and live birth outcomes, helping move fertility care away from assumption and toward a more evidence-based approach to embryo management and patient counseling.

UN ESCAP’s ‘Femtech in South-East Asia: Unlocking innovation for women’s health’ stood out for a different reason.

Rather than focusing on one product area or one clinical question, it mapped an entire emerging ecosystem.

The report examined the state of femtech across key South-East Asian markets, documented barriers such as financing gaps, stigma, weak ecosystem support, and data challenges, and then translated that research into practical recommendations for governments, investors, founders, and ecosystem builders.

In many ways, all three finalists are winners.

Each project excelled on core evaluation criteria including originality, relevance, coherence, effectiveness, efficiency, impact, and sustainability.

Each also offered something genuinely valuable to the future of women’s health: stronger evidence, clearer decision-making, more informed product development, and greater visibility for unmet needs that have gone too long without sufficient attention.

The final decision was therefore a genuine head-to-head race.

The jury supported its discussion with a numerical scoring approach, but it also looked carefully at systems impact: the extent to which a project not only advances one intervention, but improves the wider conditions under which innovation can emerge, scale, and endure.

That perspective mattered in this category, because the strongest research is not always only the most technically impressive; sometimes it is the research that opens doors for many future innovations to follow.

On that basis, the OncoGenomX Jury selected UN ESCAP as the winner of the Research Award.

The decisive factor was not simply that the report was comprehensive, though it was.

It was that the project helps change the environment around innovation itself.

It provides a practical roadmap for strengthening research, improving data governance, expanding founder support, addressing gender bias in investment, scaling innovative finance, and integrating women’s health more fully into policy and development agendas.

That broader enabling effect is what distinguished the UN ESCAP project. Natural Cycles demonstrated outstanding research translation, and IVI RMA demonstrated exceptional clinical rigor.

UN ESCAP, however, showed how research can influence the structures that determine whether many other femtech solutions will ever be funded, adopted, trusted, and scaled. In that sense, its impact reaches beyond one company, one product, or one clinical pathway, and toward a healthier innovation landscape overall.

Warm congratulations again to all finalists and nominees.

And special congratulations to UN ESCAP on receiving the OncoGenomX Research Award at the Femtech World Awards 2026.

The jury’s decision reflects deep respect for all three projects and a shared belief that women’s health advances fastest when excellent science is paired with the power to reshape the systems around it.

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WEC Chair calls out Health Minister’s delay on banning BBLs and other harmful cosmetic procedures

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WEC chair Sarah Owen has criticised delays over a ban on high harm cosmetic procedures, including liquid BBLs.

The Women and Equalities Committee has published a letter from health minister Karin Smyth after the government missed the 18 April deadline to respond to the committee’s report on cosmetic procedures.

The report, published on 18 February, recommended that high harm procedures such as liquid Brazilian butt lifts, known as BBLs, should be banned immediately without further consultation.

MPs said the government is “not moving quickly enough” in introducing a licensing system for non-surgical cosmetic procedures and “should accelerate regulatory action”.

They also warned that “this lack of timely action is fostering complacency in self-regulation” within the industry.

In her letter, Smyth said the Department of Health and Social Care had “taken the decision to first of all focus on introducing legal safeguards for the cosmetic procedures posing the highest risks and I can confirm that we plan to consult on draft regulations in June”.

The letter added:

“Our intention is to issue a formal government response to the WEC report, once our consultation setting out our proposed approach and underpinning legislation is published.

“I acknowledge the concerns around the government’s pace of delivery in this area but, as you will appreciate, this is a complex area of policy and striking the balance between increased patient safety, placing new requirements on businesses and introducing proportionate and enforceable regulation is challenging.

“I recognise that regulation has not kept pace with the expansion of the aesthetics industry and, on that basis, I can assure you that we are committed to implementing licensing in the current parliament.”

Owen, chair of the Women and Equalities Committee and Labour MP, said:

“Further consultation and delay on clamping down on high harm procedures such as liquid BBLs is unacceptable. It allows unscrupulous people to continue to put women at risk and lets down those who have lost loved ones following these practices or who have come to serious harm themselves.

“As WEC’s report warned back in February, procedures that are deemed high risk such as liquid BBLs and liquid breast augmentations, which have already been shown to pose a serious threat to patient safety, should be banned immediately.

“While it is positive to hear a licensing system for non-surgical cosmetic procedures will be introduced within this Parliament, this issue requires faster regulatory progress, particularly in high harm areas, and the Government is not moving quickly enough.

“The Committee previously heard a powerful and shocking testimony from a woman who developed sepsis after having a liquid BBL. Her experience and those of many others provides clear evidence of the need to tackle this evolving wild west.”

A liquid BBL is a non-surgical procedure intended to alter the shape of the buttocks.

Sepsis is a potentially life-threatening response to infection that can lead to organ damage if not treated quickly.

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Menopausal hormone therapy could prevent bone loss or lower fracture risk – study

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Women who do not use menopausal hormone therapy have a greater risk of developing osteopenia or osteoporosis, conditions that weaken bones and can lead to fractures, disability and loss of independence, new research suggests.

The retrospective cohort study included 387 postmenopausal women who underwent DXA scans between 2021 and 2025. A DXA scan is an imaging test used to measure bone mineral density.

Participants were classed as menopausal hormone therapy users, who made up 33 per cent of the group, or non-users, who made up 67 per cent.

Low bone mineral density was defined as osteopenia, where bones are weaker than normal, or osteoporosis, where bones become more fragile and more likely to break.

Women taking menopausal hormone therapy had about 69 per cent lower risk of low bone mineral density in the spine and hip compared with those not using it.

The association remained after researchers accounted for age, time since menopause, vitamin D levels, smoking and other health conditions.

Diego Espinoza-Peralta, vice president of the Mexican Society of Nutrition and Endocrinology and principal investigator at Investigación Médica Sonora, said: “For years, many women have avoided menopausal hormone therapy because of safety concerns and warning labels.

“This study revisits that narrative and shows that menopausal hormone therapy may have an important added benefit: protecting bone health. That shifts the conversation from ‘avoid if possible’ to ‘reconsider in the right patient.’

“In simple terms: menopausal hormone therapy appears to independently protect bones, not just by coincidence.”

The findings suggest hormone therapy could help some women find relief from menopausal symptoms while preventing bone loss or lowering fracture risk.

Espinoza-Peralta said: “Clinicians may begin to weigh its benefits more carefully, especially in women early after menopause, potentially improving long-term health and quality of life.”

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